This moisturizing corticosteroid lotion is designed to REDUCE PLAQUE PSORIASIS SYMPTOMS such as plaque buildup, scaling, redness, and dryness in 2 weeks for patients 12 and up1-3
help take your rsvp from “yes” to...
With ULTRAVATE® Lotion, clear or almost clear skin is possible in 2 weeks1
WhY ULTRAVATE® Lotion?
Patients experienced improvement in plaque psoriasis symptoms like plaque buildup, redness, and scaling
Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency.
Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surface-to-body mass ratios.
Common side effects with ULTRAVATE® Lotion1
The most common side effects of ULTRAVATE® Lotion include reactions at the application site like small visible blood vessels (spider veins), skin thinness, and headache. These are not all of the possible side effects of ULTRAVATE® Lotion. Contact your dermatologist for medical advice about side effects. Burning/stinging occurred in less than 1% of adult patients1
See the Ultravate® 2-Week Difference
Adult patient images below represent results after using ULTRAVATE® Lotion twice daily for two weeks.*
ULTRAVATE® Lotion increases absorption into the skin and moisturizes dry, thick plaques1-3,5
ULTRAVATE® Lotion is easy to spread on large body surface areas and offers increased skin hydration3,4
Made with ingredients to increase and maintain skin moisturization1,3
USING ULTRAVATE® LOTION1
Apply a thin layer to the affected skin twice daily for up to 2 weeks. Rub in gently.
Treatment beyond 2 weeks is not recommended. Discontinue ULTRAVATE® Lotion
when control is achieved. If there is no improvement after 2 weeks, talk to your doctor.1
In adult clinical trials, less than 1% of patients experienced side effects with ULTRAVATE® Lotion.1
Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression, adrenal insufficiency, and Cushing’s syndrome.
Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children.
ULTRAVATE® Lotion should be stored at 25°C (77°F). It should not be frozen.1
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References: 1. ULTRAVATE® Lotion [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2020. 2. National Psoriasis Foundation. Topical steroid potency chart. https://www.psoriasis.org/potency-chart/. Accessed September 25, 2020. 3. Grove G, Zerweck C, Houser T, et al. Occlusivity and moisturization potential of a new lotion formulation of halobetasol propionate, 0.05%. Poster presented at: 74th Annual Meeting of the American Academy of Dermatology; March 4-8, 2016; Washington, DC. 4. Pariser D, Bukhalo M, Guenthner S, et al. Two multicenter, randomized, double-blind, parallel group comparison studies of a novel enhanced lotion formulation of halobetasol propionate lotion, 0.05% versus its vehicle lotion in adult subjects with plaque psoriasis. J Drugs Dermatol. 2017;16(3):234-240. 5. Feldman SR. Relative efficacy and interchangeability of various clobetasol propionate vehicles in the management of steroid-responsive dermatoses. Curr Ther Res Clin Exp. 2005;66(3):154-171. 6. InformedHealth.org. Eczema: steroids and other topical medications. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG). 2017. Available from: https://www.ncbi.nlm.nih.gov/books/ NBK424899/.
INDICATIONS AND USAGE
ULTRAVATE (halobetasol propionate) Lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
IMPORTANT SAFETY INFORMATION
Usage: Limit use to 50 g/week. Discontinue treatment when control is achieved. If no improvement is seen within 2 weeks, reassess diagnosis. Treatment beyond 2 consecutive weeks is not recommended. Avoid use on the face, scalp, groin, or axillae.
Effects on Endocrine System: Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. Systemic absorption may require evaluation for HPA axis suppression. Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. Children may be more susceptible to systemic toxicity when treated with topical steroids.
Local Adverse Reactions: Local adverse reactions with topical steroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection and miliaria. These may be more likely to occur with occlusive use, prolonged use or more potent corticosteroids, including ULTRAVATE.
Concomitant Skin Infections: Use an appropriate antimicrobial agent if a skin infection is present or develops.
Allergic Contact Dermatitis: Discontinue ULTRAVATE lotion if allergic contact dermatitis is established.
In clinical trials the most common adverse reactions (≥1%) were telangiectasia, application site atrophy, and headache.
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.